22596 Federal Register / Vol. 75, No. 82 / Thursday, April 29, 2010 / Notices 

Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Average 

hours per 

respondent 

Total hour 

burden 

Healthy Start Grantee Web Survey ..................................... 102 1 102 4.0 408 

Total .............................................................................. 102 1 102 4.0 408 

E-mail comments to 

paperwork@hrsa.gov or mail to the 

HRSA Reports Clearance Officer, Room 

10–33, Parklawn Building, 5600 Fishers 

Lane, Rockville, MD 20857. Written 

comments should be received within 60 

days of this notice. 

Dated: April 20, 2010. 

Sahira Rafiullah, 

Director, Division of Policy and Information 

Coordination. 

[FR Doc. 2010–9974 Filed 4–28–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; NIH Toolbox for Assessment 

of Neurological and Behavioral 

Function 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Institute on Aging (NIA), the 

National Institutes of Health (NIH) will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection 

Title: NIH-Toolbox for Assessment of 

Neurological and Behavioral Function. 

Type of Information Collection Request: 

New. Need and Use of Information 

Collection: The overall goal of the 

Toolbox project is to develop unified, 

integrated methods and measures of 

four domains of neurological and 

behavioral functioning (cognitive, 

emotional, motor and sensory) for use in 

large longitudinal or epidemiological 

studies where functioning is monitored 

over time. The current phase 

(‘‘Norming’’), will involve a large sample 

of 5,660 for the purpose of establishing 

comparative norms. We will screen 

52,800 households for members’ age, 

gender and primary language to recruit 

the participants. The targeted 

population will be non-institutionalized 

U.S. residents, aged 3–85, with 66% 

English-speaking and 34% Spanishspeaking. Frequency of Response: Once 

to the screener, and once or twice 

(depending on subsample). Affected 

Public: Individuals. Type of 

Respondents: U.S. residents (persons 

aged 3–85 years). The annual reporting 

burden is as follows: Estimated Number 

of Respondents: 52,800 for the screener 

and 5,660 for the Toolbox measures; 

Estimated Number of Responses per 

Respondent: 1 screening and 1–2 for 

selected participants; Average Burden 

Hours per Response: For the screener, 

0.1 and 2.49 for selected participants; 

and Estimated Total Annual Burden 

Hours Requested: 21,480. The 

annualized cost to respondents is 

estimated at: $393,250. There are no 

Capital Costs, Operating Costs, and/or 

Maintenance Costs to report. 

Type of respondents 

Estimated 

number of 

respondents 

Estimated 

number of responses per 

respondent 

Average burden 

hours per 

response 

Estimated total 

annual burden 

hours 

requested 

Screening 

Household member ....................................................................................... 52,800 1 .1 5,280 

Adults 

Not affiliated with participating child, single assessment .............................. 1710 1 3 5,130 

Not affiliated with participating child, two assessments ................................ 350 2 3 2,100 

Non-participating parent of participating child, single assessment ............... 910 1 0 .5 455 

Non-participating parent of participating child, two assessments ................. 350 2 0 .5 350 

Participating parent of participating child, single assessment ....................... 390 1 3 .5 1,365 

Participating parent of participating child, two assessments ......................... 150 2 3 .5 1,050 

Children 

Single assessment ......................................................................................... 1300 1 2 .5 3,250 

Two assessments .......................................................................................... 500 2 2 .5 2,500 

Totals ...................................................................................................... *54,600 ........................ .......................... 21,480 

*Includes one adult from each screened household plus selected child participants. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information, including the validity of 

the methodology and assumptions used; 

(3) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

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Federal Register / Vol. 75, No. 82 / Thursday, April 29, 2010 / Notices 22597 

technological collection techniques or 

other forms of information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Molly Wagster, 

Ph.D., Division of Neuroscience, 

National Institute on Aging, NIH, DHHS, 

7201 Wisconsin Avenue, Suite 350, 

Bethesda, Maryland 20892–9205 or call 

non-toll-free number 301–496–9350 or 

e-mail your request, including your 

address to: wagsterm@nia.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: April 23, 2010. 

Melissa Fraczkowski, 

National Institute on Aging Project Clearance 

Liaison, National Institutes of Health. 

[FR Doc. 2010–10015 Filed 4–28–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. Docket No. FDA–2009–N–0506] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Bar Code Label 

Requirement for Human Drug and 

Biological Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by June 1, 

2010. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0537. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Bar Code Label Requirement for 

Human Drug and Biological Products— 

OMB Control Number 0910–0537— 

Extension 

In the Federal Register of February 

26, 2004 (69 FR 9120), we issued new 

regulations that required human drug 

product and biological product labels to 

have bar codes. The rule required bar 

codes on most human prescription drug 

products and on over-the-counter (OTC) 

drug products that are dispensed under 

an order and commonly used in health 

care facilities. The rule also required 

machine-readable information on blood 

and blood components. For human 

prescription drug products and OTC 

drug products that are dispensed under 

an order and commonly used in health 

care facilities, the bar code must contain 

the National Drug Code number for the 

product. For blood and blood 

components, the rule specifies the 

minimum contents of the machinereadable information in a format 

approved by the Director, Center for 

Biologics Evaluation and Research as 

blood centers have generally agreed 

upon the information to be encoded on 

the label. The rule is intended to help 

reduce the number of medication errors 

in hospitals and other health care 

settings by allowing health care 

professionals to use bar code scanning 

equipment to verify that the right drug 

(in the right dose and right route of 

administration) is being given to the 

right patient at the right time. 

Most of the information collection 

burden resulting from the final rule, as 

calculated in table 1 of the final rule (69 

FR 9120 at 9149), was a one-time 

burden that does not occur after the 

rule’s compliance date of April 26, 

2006. In addition, some of the 

information collection burden estimated 

in the final rule is now covered in other 

OMB-approved information collection 

packages for FDA. However, parties may 

continue to seek an exemption from the 

bar code requirement under certain, 

limited circumstances. Section 

201.25(d) (21 CFR 201.25(d)) requires 

submission of a written request for an 

exemption and describes the contents of 

such requests. Based on the number of 

exemption requests we have received, 

we estimate that approximately two 

exemption requests may be submitted 

annually, and that each exemption 

request will require 24 hours to 

complete. This would result in an 

annual reporting burden of 48 hours. 

In the Federal Register of November 

6, 2009 FR 74 57495, FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received on the information collection. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section Number of 

Respondents 

Number of Responses 

per Respodent 

Total Annual 

Responses 

Hours per 

Response Total Hours 

201.25(d) 2 1 2 24 48 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

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